BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESSION PATIENT MONITOR (MR200)

    MDR report key: 15439767 · Received September 16, 2022

    Report

    Report Number
    1051786-2022-00047
    Event Type
    Death
    Date Received
    September 16, 2022
    Date of Event
    August 22, 2022
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838033764
    PMA / PMN Number
    K131382
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED WITH REFERENCE TO MANUFACTURER'S REPORT NUMBER 1051786-2022-00047. THE REPORTED PROBLEM WAS CAUSED BY A LACK OF COMMUNICATION DUE TO MRI DOOR CLOSED AND NO INSTALLED ANTENNAS. THE CUSTOMER WAS AWARE THIS WAS AN ISSUE AND DID NOT ATTEMPT TO ORDER ANY ADDITIONAL ANTENNAS UNTIL AFTER THIS EVENT. THE CAUSE OF THE EVENT WAS THE LOSS OF CONNECTION DUE TO A LACK OF INSTALLED ANTENNAS. IT IS THE CUSTOMER'S RESPONSIBILITY TO PURCHASE AN ANTENNA THROUGH THE PROPER CHANNELS. WE WILL CONSIDER THE CUSTOMER RESOLVED THE ISSUE WITH PURCHASE OF AN ANTENNA. THE DEVICE REMAINED ON SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE BETWEEN THE MR200 AND IP5 MONITOR. PATIENT WAS REPORTED TO HAVE STOPPED BREATHING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE BETWEEN THE MR200 AND IP5 MONITOR. PATIENT WAS REPORTED TO HAVE STOPPED BREATHING. THE DEVICE LOSING CONNECTIVITY CAUSED A LAPSE IN MONITORING OF THE PATIENT. THE PHILIPS TECHNICAL CONSULTANT (TC) CONFIRMED THE EVENT. THE TC WAS ON SITE AND UNABLE TO RETRIEVE DATA LOGS FROM THE EVENT. THE TC CONFIRMED THAT THE COMMUNICATION WAS LOST WHEN THE MRI DOOR WAS CLOSED. THE CUSTOMER DECLINED SERVICE, BUT REQUESTED AN ANTENNA TO IMPROVE COMMUNICATION. THE CAUSE OF THE EVENT WAS THE LOSS OF CONNECTION. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED. THE DEVICE REMAINED ON SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE BETWEEN THE MR200 AND IP5 MONITOR. PATIENT WAS REPORTED TO HAVE STOPPED BREATHING.THE DEVICE LOSING CONNECTIVITY CAUSED A LAPSE IN MONITORING OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123407 EXPRESSION PATIENT MONITOR (MR200) EXPRESSION PATIENT MONITOR (MR200) MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 866120 00884838033764

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death